ZALEPLON capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)

Available from:

Rising Health, LLC

INN (International Name):

ZALEPLON

Composition:

ZALEPLON 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials  under CLINICAL PHARMACOLOGY ). They have not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Zaleplon capsules are contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon capsules (see WARNINGS ). - with hypersensitivity to zaleplon or any excipients in the formulation (see PRECAUTIONS ). Zaleplon is classified as a Schedule IV controlled substance by federal regulation.  Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often i

Product summary:

Zaleplon Capsules USP, 5 mg are Opaque green/opaque pale green colored, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘E19’ on opaque green cap and ‘5 mg’ on opaque pale green body with black ink.     Bottles of 100        NDC 57237-239-01 Zaleplon Capsules USP, 10 mg are Opaque green/opaque light green colored, size ‘4’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘E20’ on opaque green cap and ‘10 mg’ on opaque light green body with black ink.     Bottles of 100        NDC 57237-240-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a light-resistant container as defined in the USP. Dispense  with  Medication  Guide  available  at : http://www.risingpharma.com/med-guides.html Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/19/1993 Revised: 09/2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Rising Health, LLC
----------
MEDICATION GUIDE
Zaleplon Capsules USP CIV
(zal' e plon)
Rx only
Read this Medication Guide before you start taking zaleplon and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your doctor about your
medical condition or treatment. You and your doctor should talk about
zaleplon when you start taking it
and at regular checkups.
What is the most important information I should know about zaleplon?
Zaleplon may cause serious side effects including complex sleep
behaviors that may cause serious injury
and death. After taking zaleplon, you may get up out of bed while not
being fully awake and do an
activity that you do not know you are doing (complex sleep behaviors).
The next morning, you may not
remember that you did anything during the night. These activities may
occur with zaleplon whether or not
you drink alcohol or take other medicines that make you sleepy.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1. Take zaleplon exactly as prescribed
•
Do not take more zaleplon than prescribed.
•
Take zaleplon right before you get in bed, not sooner.
2. Do not take zaleplon if you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food,
talking on the phone or having sex while not fully awake) after taking
zaleplon
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines.
Your doctor will tell you if you can take zaleplon with your other
medicines
•
cannot get a full night’s sleep
3. Stop taking zaleplon and call your doctor right away if you find
out that you have done any of the
above activities after taking zaleplon.
What is zaleplon?
Zaleplon is a sedative-hypnotic (sleep) medicine. Zaleplon is used in
adults for the short-term treatment
of the symptom of trouble falling asleep from insomnia. Zalepl

Summary of Product characteristics

ZALEPLON - ZALEPLON CAPSULE
RISING HEALTH, LLC
----------
ZALEPLON CAPSULES USP CIV
RX ONLY
WARNING: COMPLEX SLEEP BEHAVIORS
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZALEPLON.
SOME OF THESE EVENTS
MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE ZALEPLON
IMMEDIATELY IF A PATIENT
EXPERIENCES A COMPLEX SLEEP BEHAVIOR (SEE CONTRAINDICATIONS AND
COMPLEX SLEEP
BEHAVIORS UNDER WARNINGS)_._
DESCRIPTION
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine
class. The chemical name of
zaleplon is
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide.
Its molecular
formula is C
H N O, and its molecular weight is 305.34. The structural formula is
shown below.
Zaleplon USP is a white to light pale yellow, crystalline powder that
is practically insoluble in water
and sparingly soluble in alcohol or propylene glycol. Its partition
coefficient in octanol/water is
constant (log PC = 1.23) over the pH range of 1 to 7.
Zaleplon capsules USP contain zaleplon USP as the active ingredient.
Inactive ingredients consist of
microcrystalline cellulose, lactose monohydrate, pregelatinized starch
(maize), sodium lauryl sulfate,
colloidal silicon dioxide, and stearic acid. The empty hard gelatin
capsule shells contain FD&C Blue
#1, FD&C Green #3, FD&C Yellow #5, titanium dioxide, and gelatin. The
capsules are printed with
edible ink containing black iron oxide and shellac.
Meets the USP Dissolution Test - 2.
17
15
5
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS AND MECHANISM OF ACTION
While zaleplon is a hypnotic agent with a chemical structure unrelated
to benzodiazepines, barbiturates,
or other drugs with known hypnotic properties, it interacts with the
gamma-aminobutyric acid-
benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the
GABA-BZ receptor chloride
channel macromolecular complex is hypothesized to be responsible for
some of the pharmacological
properties of benzodiazepines, which